Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C Registry

Abstract

Introduction: Percutaneous coronary interventions (PCI) in bifurcations are still challenging and are associated with higher risks of periprocedural complications as well as restenosis and stent thrombosis. The aim of this paper was to summarize 12 months of clinical results of the prospective, first-inman registry assessing the BiOSS LIM C stent (Balton, Poland). Material and methods: In the prospective two-center registry we enrolled patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and stable coronary artery disease. Provisional T-stenting was the default treatment strategy. The primary endpoint was defined as the rate of cardiac death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) in 12-month follow-up. Results: The study population consisted of 95 patients (mean age 66.8 ±9.8 years, 17.9% were females). A BiOSS LIM C stent was implanted in the left main (LM) in 53 (55.8%) cases. There were 25.2% of patients with NSTE-ACS, 33.7% with diabetes, 90.5% with hypertension, and 53.7% had previous MI. The device success rate was 100%. An additional regular drug-eluting stent was deployed in the side branch in 18.9% of cases. Proximal optimization technique and final kissing balloon (FKB) technique were used in 53.7% and 30.5% of cases, respectively. MI type 4a was registered in four cases (4.2%). At 12 months the MACE rate was 9.5%, cardiac death 1.1%, MI 2.1% and clinically driven TLR 6.3%. All incidents, apart from one TLR, appeared in the LM subgroup. Conclusions: Our registry might suggest that PCI using the BiOSS LIM C in coronary bifurcations is feasible and might be an option for percutaneous revascularization.

The Randomized, Multicenter, Open-Label, Controlled POLBOS 3 Trial Comparing Regular Drug-Eluting Stents and the Sirolimus-Eluting BiOSS LIM C Dedicated Coronary Bifurcation Stent: Four-Year Results

“…The results of POLBOS 3 are quite comparable to those observed in the first-in-human study with the BiOSS LIM C [13]. Similarly, the device success rate was 100%.…”

“…After both successful preclinical testing and a first-in-human study of the BiOSS LIM C stent, a randomized study (POLBOS 3) was designed [11][12][13].…”

Cardiovascular Stents: A Review of Past, Current, and Emerging Devices

“…Another example of design improvement is the manufacture of bifurcation stents, which can overcome the challenges faced during bifurcation procedures [19,138]. PCI in bifurcations is associated with higher rates of periprocedural complications, in-stent restenosis, and stent thrombosis [139]. Dedicated bifurcation stents can be chosen for this procedure as they make it possible for the operator to perform the lesion stenting without the need to rewire the side branch [140].…”

“…bifurcations is associated with higher rates of periprocedural complications, in-stent restenosis, and stent thrombosis [139]. Dedicated bifurcation stents can be chosen for this procedure as they make it possible for the operator to perform the lesion stenting without the need to rewire the side branch [140].…”